A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL

Official title

A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)

Overview

This is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL).

Detailed description

The study aims to enroll approximately 22 adult patients who have received at least two prior systemic therapies, including anti-CD20 monoclonal antibody treatment. The primary endpoint is the complete response rate (CR), while secondary endpoints include objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessment. The trial will be conducted at multiple centers in China, with an estimated study duration from May 2025 to May 2027.

Interventions

• Drug Mosunetuzumab
  * Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg * Cycles 2-8: 30 mg every 3 weeks * Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs.
• Drug Tislelizumab
  \- Cycles 2-8: 200 mg IV every 3 weeks

Primary outcome measures

• best of complete response rate (CR) [Time frame: up to the end of 8/17 cycles of treatment(each cycle 21 days)]

Secondary outcome measures (4)

• Overall Response Rate (ORR) [Time frame: up to the end of 8/17 cycles of treatment(each cycle 21 days)]
• Duration of Response (DoR) [Time frame: up to 2 years]
• Progression-free survival (PFS) [Time frame: Assessed every 3 months during follow-up, up to 2 years]
• OS [Time frame: Assessed every 3 months during follow-up, up to 2 years]

Eligibility criteria

Inclusion criteria

• Signed written informed consent.
• Age ≥18 years.
• Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).
• Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.
• ECOG performance status 0-1.
• Expected survival ≥12 weeks.
• Measurable disease (longest diameter >1.5 cm).
• Adequate organ function:

• Hepatic function: Total bilirubin ≤1.5×ULN; AST/ALT ≤3×ULN.
• Hematologic function: ANC ≥1.5 × 10⁹/L; Platelets ≥75,000/μL; Hemoglobin ≥10.0 g/dL.
• Renal function: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula).
• Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.

Exclusion criteria

• Inability to comply with study hospitalization and restrictions.
• Active infections (including tuberculosis) or immunocompromised status.
• Prior history of severe hypersensitivity to similar agents.
• CNS involvement of lymphoma.
• Pregnant or breastfeeding women.
• Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.
• Receipt of live attenuated vaccines within 4 weeks before enrollment.
• Use of systemic immunosuppressants within 2 weeks prior to first dose.
• History of drug or alcohol abuse in the past 12 months.
• Any condition deemed inappropriate for study participation by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07031700 · FL-RR-MOS01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗